Biotech Strategy Blog

Commentary on Science, Innovation & New Products with a focus on Oncology, Hematology & Cancer Immunotherapy

Posts tagged ‘Pharmaceutical’

In a case of national significance to the pharmaceutical and biotechnology industry, the United States Supreme Court on January 7 decided to hear the case of Sorrell (Attorney General of Vermont) v. IMS Health Inc & Pharmaceutical Research and Manufacturers of America (PhRMA).

This case is about whether States have the right to regulate how physician prescriber data is sold and used, and whether physicians have a right to privacy in the use of their personal information. In Vermont, the legislature enacted a law that allowed prescribers on their annual licensing renewal to opt-out of allowing the use of information that would identify them in any data used for marketing or promotion of prescription drugs.

The Vermont law also states that “pharmaceutical manufacturers and pharmaceutical marketers shall not use prescriber-identifiable information for marketing or promoting a prescription drug” unless the prescriber consents. Vt Stat. Ann. 18, § 4631(d).

Without the identity of prescribers, companies such as IMS Health would not be able to provide the level of granularity about prescribing behavior that allows targeted detailing by medical representatives to take place.

Currently, individual patient names in the prescription data are redacted by encryption technology, but this process results in a unique identifier for each patient. Tracking this unique patient identifier coupled with the name of the physician allows the prescribing behavior of different doctors for a patient to be monitored. This has major significance to medical reps allowing them to identify physicians who: do or do not prescribe their products, switch patients to competitor products or use lower cost generics.

The Vermont legislature in 2009 passed the Prescription Confidentiality Law, 18 V.S.A. § 4631 that requires prescribers to give their consent to the use of personally identifiable information and allowed them the ability to opt-out at the time of license renewal.  In the absence of consent, all other prescription data was still available for use in marketing and promotion, but not the identity of the prescribing doctor. Not surprisingly this law was not well received by data mining companies such as IMS Health and pharmaceutical manufacturers.

The District Court upheld the legal challenge to the Vermont law, while the United States Court of Appeals for the Second Circuit over-turned it.  Similar laws in Maine and New Hampshire have been upheld by the United States Court of Appeals for the First Circuit, raising a circuit conflict that the Supreme Court has now decided to resolve.

The Supreme Court decision will not only impact Vermont, but all those States who are interested in regulating this area.

The question presented to the Supreme Court for answer is:

“Whether a law that restricts access to information in nonpublic prescription drug records and affords prescribers the right to consent before their identifying information in prescription drug records is sold or used in marketing runs afoul of the First Amendment.”

The case of Sorrell v IMS Health raises multiple questions that the Supreme Court will have to consider at the intersection of information technology, privacy and commerce:

  1. If pharmacists are required by law to gather prescription data that identifies individual physicians and their prescribing habits, do States have the authority to regulate the use of this information?
  2. Does pharmacy prescribing data constitute commercial speech that is protected by the First Amendment to the United States Constitution?
  3. And if it is protected, does the Vermont law meet the standard to regulate the use of this data in the marketing and promotion of prescription drugs?

These are all difficult questions of law, and I am sure that legal scholars will be busy writing amicus briefs in support of both sides of the debate.

However, I predict the decision in this case will also have a far-reaching impact on electronic privacy rights and the extent to which data mining can be regulated, not only in the pharmaceutical industry but across all industries.

Sales of pharmaceuticals are the fuel of the industry and provide the $ for investment in R&D, but could there be life without such in-depth IMS data?  Although medical sales might be less efficient and less targeted, the industry would survive and sales would still take place.  When I lived in the United Kingdom over ten years ago, IMS only provided prescribing data on the equivalent of a zip code level, but medical reps were still effective without knowing the identity of individual prescribers.  You could still work out which areas in a territory were important, and the key practices to target.

The case of Sorrell v IMS Health is one that all U.S. biotechnology and pharmaceutical companies will be watching with great interest given the tremendous impact it could have on the industry business model.  I look forward to writing an update as the case develops and oral argument is scheduled.

A company I have been watching for a while is Philadelphia based Avid Radiopharmaceuticals, now a wholly owned subsidiary of Lilly. They have a novel imaging biomarker, florebetapir (18F-AV-45) in development for the detection of Alzheimer’s disease.

In a press release last week, Lilly announced that the FDA had assigned a priority review to the marketing application of florebetapir. The Peripheral and Central Nervous System Drugs Advisory Committee of the FDA meet on January 20, 2011.

Bayer have a competitor product in development, forebetapen (BAY 94-9172). Both florebetapir and florebetapen are 18F radiolabelled imaging biomarkers that bind to amyloid plaque in the brain.  When used in conjunction with a Positron Emission Tomography (PET) scan, they enable the accumulation of amyloid that occurs in Alzhemeir’s disease to be visualized.

Phase 3 trial results for florebetapir published earlier this year showed that the brain amyloid burden seen in the PET scans positively correlated with the plaques seen in autoposies of the same patients.  Proof that what the imaging biomarker shows is an accurate representation of the underlying pathology.

What makes the use of florebetapen and florebetapir interesting is that it is already common practice to use imaging tracers with PET scans. Fluorodeoxyyglucose (FDG) is widely used in the diagnosis, staging and treatment of oncology patients as a result of its ability to show the intense glucose uptake that occurs with most cancers.

Both Avid and Bayer products are most likely to be approved based on the clinical data presented to date.  It will be interesting to see the prices that they intend to charge.

As for the market opportunity, they are likely to have a role to play in the early diagnosis of patients with mild cognitive impairment, since at present it is difficult to diagnose these patients and differentiate Alzheimer’s disease from other forms of dementia.  Most likely, models will be developed that look for a correlation between accumulation of amyloid plaque and decline in cognitive function, from which a probability of developing Alzheimer’s disease can be calculated.

Imaging biomarkers are likely to place an increasingly important role in the development of new products by biotechnology companies and in the design of clinical trial endpoints.

Uveal melanoma is a common cancer of the eye that involves the iris, ciliary body and choroid.  It is a disease that hits 2000 people per year in the United States and is common in those over 50.  Standard treatment involves removal of the eye or radiotherapy. There is an unmet need for systemic drug therapy.

Mutations in the BRAF gene (a member of the Raf family that encodes a serine/threonine protein kinase) have been found in many skin melanomas.  In 80% of the cases, a single point mutation in exon 15 (T1799A) has been shown to occur.  Some new agents in development such as PLX4032, ipilumumab, GSK2118436 have shown promise in advanced skin melanoma, but research suggests that BRAF may not be the key to Uveal melanoma.

Henriquez et al, in a paper published in Investigative Ophthalmology & Visual Science showed that the T1799A BRAF mutation was only present in 9 of 19 iris melanoma tissue samples, but only in one case of uveal melanoma, suggesting differences in the genetic and clinical differences between the two.

Recently, two papers have been published that provide new insight into this intraocular cancer. In the December 2, 2010 issue of the New England Journal of Medicine, Van Raamsdonk et al, found mutations of either the GNAQ or GNA11 gene to be present in 83% of uveal melanomas that were sequenced (n=713).

Harbour et al, in the December 3, 2010 issue of Science reported findings of a frequent mutation of BAP1 in metastasizing uveal melanomas. They found that in 26 of 31 (84%) of uveal melanoma tumors they examined, there was a mutation of BAP1, the gene encoding BRCA1 associated protein 1 (BAP1) on chromose 3p21.1. The results published in Science, “implicate loss of BAP1 in uveal melanoma metastasis and suggest that BAP1 pathway may be a valuable therapeutic target.”

The data suggests that there may be multiple pathways involved in uveal melanoma.  It is promising to see translational medicine in action, with scientists seeking to understand the molecular basis of a disease so that targeted therapies can be developed.  Uveal melanoma only strikes a relatively small number of patients, but if a highly effective drug can be developed, this could be a market opportunity worth pursuing.

Welcome to the biotech strategy blog which provides commentary and insight on current news and emerging trends in biotechnology.

As a strategy and marketing consultant with a background in clinical development I am interested in how biotechnology companies grow, manage alliances, partner with CROs and bring new products to market. I hope that you will find posts on this blog to be informative and interesting.

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